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Study identifier: NCT07225621 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma

Condition: Glioblastoma · GBM  ·  Sponsor: Alpheus Medical, Inc.

PhasePhase 2
Planned participants103
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma that uses an investigational drug (5-ALA) combined with a non-invasive ultrasound device (LIDU) to target tumor cells. Patients meeting the entry requirements to be in the study, will be equally randomly assigned to receive the study device plus the active study drug plus active ultrasound, or to a "sham" procedure where the ultrasound is not being activated and the study drug is a placebo (looks the same but does not contain active drug). Neither the patient or the investigator will know who is in the active group or not. Both groups will continue to receive the standard therapy of oral Temozolomide.

This description comes directly from the study's public registry record.

Talk to the study team

Ann-Marie VP, Clinical Operations  ·  4842521960  ·  AMHulstine@alpheusmedical.com

Always discuss trial participation with your own doctor first.

Locations (11)

Dana Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting
Mayo ClinicRochester, Minnesota, United StatesRecruiting
Albany Medical CenterAlbany, New York, United StatesRecruiting
Dent Neurologic InstituteBuffalo, New York, United StatesRecruiting
Northwell HealthLong Island City, New York, United StatesRecruiting
New York LangoneNew York, New York, United StatesRecruiting
Columbia UniversityNew York, New York, United StatesRecruiting
Memorial Sloan Kettering Cancer CenterNew York, New York, United StatesRecruiting
University of RochesterRochester, New York, United StatesRecruiting
Ohio State UniversityColumbus, Ohio, United StatesRecruiting
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07225621